This invention relates generally to medical devices and more particularly to hemostatic devices for the closure of various openings or incisions in the body of a patient.
As will be appreciated by those skilled in the art, various surgical procedures are now being carried out intravascularly or intraluminally. For example, in the treatment of vascular disease, such as atherosclerosis, it is common practice to invade the artery to insert an instrument or catheter, e.g., a balloon or other type of catheter to carry out the procedure within the artery. Such procedures usually involve the percutaneous puncture of the artery so that an introducer sheath can be inserted into the artery and thereafter the instrument or catheter itself can be inserted through the sheath to the operative position within the artery. One problem with this type of procedure is that it is oftentimes difficult to stop the bleeding at the percutaneous puncture after the procedure has been completed and after the instrument (and any introducer sheaths used therewith) have been removed.
At present, the most common treatment to stop such bleeding is by the application of manual pressure over the puncture site by a trained physician or other suitably trained medical personnel. Such manual pressure has to be applied for a sufficiently long time for hemostasis to occur so that the opening is effectively closed against further bleeding. In the case of punctures into femoral or superficial femoral arteries, the pressure may have to be applied for forty-five minutes or more for hemostasis to occur. Not only is the application of manual pressure wasteful of time by highly skilled medical professionals, the procedure results in a substantial reduction, if not virtual arrest, of the flow of blood through the vessel. Since thrombosis is one of the major side effects that may occur in the immediate post operative period, any reduction in blood flow, such as caused by the application of manual pressure, is undesirable.
Simple applicator devices have been disclosed in the patent literature for inserting an absorbent plug or member into the vagina. Such devices basically comprise a tubular element adapted to be inserted into the vagina and having a plug of absorbent material located therein. The device also includes a plunger to push the plug out of the tubular element into the vagina. The plug may also include a thread or string attached to it to enable the plug to be retrieved from the vagina. Examples of such devices are shown in U.S. Pat. Nos. 1,191,736 granted to Robertson and 1,794,221 granted to Washburn et al.
While such devices are suitable for their intended purposes, there is no suggestion of their use, nor are they particularly suitable for insertion into an opening in the wall of a blood vessel or other bodily lumen or duct to seal that opening.
U.S. Pat. Nos. 4,744,364 and 4,852,568 granted to Kensey, disclose a positioning instrument and a closure or anchor device for sealing an opening in tissue which separates one portion of the body of a living being from another portion, e.g., a puncture in a blood vessel, duct or lumen, of a living being. Various methods of use for that device are also disclosed in these patents. The positioning instrument of the Kensey invention basically comprises an elongated tubular body having an outlet at its distal end. The distal end of the device is arranged to be inserted through the puncture or other opening. In the situation where the puncture is an artery or other blood vessel, the outlet of the tubular body is inserted through the puncture so that the distal end of the device is located within the blood vessel. An anchor is disposed within the tubular body and is oriented so that it is held in a compact aligned or compressed configuration within the tubular body prior to use. The tubular body also includes an ejector in the form of a plunger-like member arranged to force the anchor out of the outlet into the portion of the being's body generally contiguous with the opening, e.g., within the interior of the blood vessel, whereupon the anchor is unfolded or expands to form an enlarged tissue engagement surface.
A retraction filament is disclosed as being secured to the anchor or closure to enable it to be pulled fully along or adjacent to the puncture after the device's tubular body has been withdrawn so that the engagement surface of the anchor or closure intimately engages or abuts the inner surface of the tissue along the puncture.
In accordance with one aspect of the disclosure of the Kensey patents, the filament is held taut or otherwise secured and placed along the surface of the patient's skin to hold the anchor or closure in position in the puncture. Preferably, the anchor or closure and the associated filament are each formed of a biodegradable material. When the anchor or closure is used for sealing punctures or incisions in blood vessels it is disclosed as being constructed so that when it is open (i.e., in its unfolded or expanded state) and in position to seal the puncture, it doesn't appreciably block the flow of blood through the blood vessel.
In U.S. Pat. No. 4,890,612 granted to Kensey, there is disclosed a further closure device for sealing a puncture or incision formed percutaneously in tissue separating two internal portions of the body of a living being and a various methods of use for that device are also disclosed. The closure device of this Kensey invention is generally in the form of a holding member, a filament, and a sealing member. The holding member is an elongated body, constructed like a toggle, and preferably formed of a biodegradable material, such as a thermoplastic polymer or polyglactide. The toggle is disclosed as being molded onto the distal end of the filament. The filament is also biodegradable, and is preferably formed of polyglactide suture material. The flexibility of the filament enables the toggle to pivot to various orientations with respect to the suture and the sealing member. The sealing member basically comprises a cylindrical plug, preferably formed of a compressed foam or other material, that is highly absorbent and which when disposed within the body swells in excess of its compressed diameter.
The closure device of this Kensey patent is arranged to be used with an insertion instrument to place the closure device within the puncture or incision to be sealed. The insertion instrument includes a tubular body member in which closure device is positioned such that the holding member is oriented with its longitudinal axis parallel to the longitudinal axis of the tubular body member. When so disposed, the holding member may compress a portion of the distal end of the sealing member. The filament member extends backward from the holding member through or along the sealing member.
The insertion instrument of this Kensey patent is introduced into the puncture or incision in the artery or any body tissue (e.g., the liver, gall bladder, lung, heart, etc.) until its distal outlet is at the desired position in the body of a patient. When this instrument is used for sealing an artery, the outlet of the insertion instrument is positioned so that it is within the artery. The insertion instrument is then operated to expel the holding member from the tubular member. Once the holding member is expelled, the instrument may be held in this position for a short period of time to allow the foam at the tip of the sealing member, that is the distal end portion of the closure device, to swell. This action effectively tilts the holding member. The insertion instrument may then be withdrawn and the closure device's filament retracted. This action pulls the closure device's sealing portion back through the puncture or incision in the artery wall until the holding portion engages the inner surface of the artery wall to stop further retraction. As the holding member comes into engagement with the arterial wall, it may effect the compression of the distal end portion of the sealing member. Moreover, the proximal end portion of the sealing member extends into the puncture or incision in the subcutaneous tissue to a point closely adjacent to the skin. These actions effectively seal the puncture or incision from the passage of blood therethrough.
The patent literature also includes various other devices for closing an opening in a blood vessel or other opening. PCT Publication No. WO 90/14796 discloses the use of an occlusion member and a locking member which are oriented across the wall of the blood vessel to seal the incision from the flow of blood therethrough. In U.S. Pat. No. 5,108,421 granted to Fowler, a plug type member is disclosed along with one or more methods of inserting the plug into an incision. Other means and techniques for closing a wound or other incision are disclosed in U.S. Pat. No. 4,606,337 granted to Zimmermann et al. and in U.S. Pat. No. 5,053,046 granted to Janese.
Despite all of the relatively recent interest in this area, there is still a need for a simple and reliable means for effecting the closure of an opening, such as in the wall of a blood vessel, duct or lumen, by plugging the opening with a gelatinous material or similar hemostatic material and an anchor or similar assembly without requiring the application of manual pressure to the incision for an extended period of time.